Every day we test our faith in mankind. We trust that the products we use have been designed, manufactured and distributed by conscientious and responsible individuals and companies. When an injury or death occurs due to a defective product, those responsible should be held accountable.
Chionuma Law Firm, LLC attorneys have extensive experience litigating product liability lawsuits. Our product liability attorneys have recovered millions for innocent victims. For a free case review, call (816) 421-5544 or 800-923-8216 (toll free) or submit our contact form.
Consider three illustrations of defective products:
The product liability attorneys with Chionuma Law Firm, LLC are skilled in prosecuting personal injury and wrongful death cases. We have worked both sides of the courtroom. We know the defendant’s weaknesses and can build your case to take advantage of those weaknesses. For aggressive representation, call (816) 421-5544 or 800-923-8216 (toll free) for a free case review.
The following are Class I recalls. Class I recalls are the most serious type of recall issued by the U.S. Food and Drug Administration (FDA) and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
SIGMA Spectrum Infusion Pump Model 35700
These units may fail without warning, causing inaccurate flow conditions (back flow, over-infusion or free flow) during use. The affected units were manufactured from January 18, 2005 through November 1, 2010. Serial numbers range from 700000 through 794213.
MOOG Medical Devices Group, Curlin Infusion Administration Sets
There is a potential for a reverse pump segment in the administration set. This malfunction could reverse the flow of fluid or medicines backwards from what was intended, potentially causing blood loss or an under-delivery of medicines or fluids.
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation
The Abacus TPN recall is due to a conflict in method of entry which may result in a 10 times higher concentration of dosage. A number of errors have been reported by Abacus software users as a result of ordering salt based parenteral nutrition ingredients on an ion based ordering template. The following catalogue numbers are included in the recall: 8300-0045 Abacus Calculator Only (Abacus CE), 8300-0046 Abacus Single Work Station (Abacus SE) and 8300-0047 Abacus Multi-Work Station (Abacus ME).
Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays
The Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays recall is because with certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results are critical and may lead to serious health consequences, including death. Lot numbers included on the recall: 163176, 163177.
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)
The HeartMate II blood pump delivers blood from the dysfunctional left ventricle of the heart to the entire body. The recall has been issued because detachment of the bend relief may allow the graft to kink or deform. This could result in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft. Also, the metal end of the bend relief may be sharp leading to erosion and cutting of the outflow graft.
Acclarent Inspira AIR Balloon Dilation System
The Inspira AIR Balloon Dilation System used to dilate and restore airflow to a patient’s airways. The system has been recalled due to the potential for the balloon to not deflate or to deflate slowly. Either scenario could result in airway obstruction until the balloon is deflated or removed which may prevent adequate blood oxygenation. This could cause temporary or permanent impairment to the patient, including cerebral anoxia.
Riata® and Riata® ST Silicone Defibrillation Leads Class I Recall
On December 15, 2011, St. Jude Medical, Inc. announced that the U.S. Food and Drug Administration (FDA) had classified its November 28, 2011 voluntary medical device advisory letter to physicians, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.
The recall of the St. Jude Riata® and Riata® ST lead wires was due to the silicone coating surrounding the lead wires eroding at a higher-than-expected rate. The Riata® and Riata® ST leads wire erosion is reported to have began as far back as 2007. The risks include perforation of the heart and, iIn some cases, the lead has perforated the patients' skin.
An estimated 79,000 Riata® and Riata® ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata® and Riata® ST family of silicone leads in December 2010. The affected model numbers are the Riata® (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
*The information on recalls obtained from the U.S. Food and Drug Administration (FDA).